MAUDE Adverse Event Report: MEDTRONIC IRELAND ONYX FRONTIER; STENT, CORONARY, DRUG-ELUTING

Model Number ONYXNG35038UX

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

An attempt was made to use one 6f telescope guide extension catheter and one 3.5x38mm onyx frontier stent to treat a severely tortuous, non-calcified lesion with 95% stenosis in the mid right coronary artery (rca).The telescope device was inspected with no issues.The telescope device was prepped per ifu with no issues.The stent was prepped.The lesion was pre-dilated with 3mm nc balloon.Resistance was encountered when advancing the telescope device.Excessive force was used during insertion/delivery.It was reported a tip detachment of the telescope occurred.A radial approach was used.A jr4 launcher guide catheter was deeply seated into the rca.The telescope made it to the mid vessel.When retracting the telescope after unsuccessful delivery of the 3.5x38mm onyx frontier stent, it was felt that the telescope retracted farther than expected based on the amount of distance it should have retracted.It was then noticed that the tip had separated.It was possible to retrieve the detached tip on the undelivered stent, as it remained attached to the stent.The stent deformed.There was no resistance noted during withdrawal of the telescope device.The telescope device was not straightened during use.Two 3.5x12mm onyx frontier stents were used to stent the area where initially the 3.5x38mm onyx frontier stent was attempted to be delivered.Finally, a 4.0x12mm onyx frontier stent was used to cover any possible remainder of the telescope, as there could have been a small fragment remaining in the vessel.It was stated that the telescope device worked the way it should, and that its capabilities were tested as there was a good amount of force required for delivery due to the tortuous anatomy.There was no issues with the launcher guide, and no issues with delivery of the shorter onyx frontier stents.The patient is alive with no further injury.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ONYX FRONTIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19132463
• MDR Text Key: 340457922
• Report Number: 9612164-2024-01860
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG35038UX
• Device Catalogue Number: ONYXNG35038UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 98 KG